iCo Therapeutics Outlines Steps to First iCo-009 Human Clinical Trial



    VANCOUVER, Sept. 4 /CNW/ - Canada-iCo Therapeutics Inc. (TSX-V: ICO) is
pleased to provide an update on the progress of iCo-009 and outline a path to
a Phase I clinical trial. iCo-009 is an oral formulation of Amphotericin B, a
drug that has been successfully used to treat systemic fungal infections for
over 50 years though its use is limited due to toxicity and intravenous
administration.
    "iCo-009 represents a near term value driver for iCo", stated Andrew Rae,
iCo Therapeutics' President & CEO. "Preliminary data currently supports iCo's
expedited clinical development path, and potentially shortens the time and
expense to reach approval. Amphotericin B possesses a therapeutic benefit that
is well known. If iCo can show that iCo-009 reaches therapeutic levels in the
bloodstream and favourable organ distribution, iCo-009 may possess a much
lower risk profile than traditional drug programs at this stage of
development."

    The path to an iCo-009 Phase I clinical trial initiation entails five key
steps:

    
    1. Establishing safety and efficacy in a model of Aspergillus fungal
       infection.
         In a press release dated March 17, 2008, iCo provided results from
         an Aspergillus fumigatus rat model. The study showed significant
         antifungal activity, minimal kidney toxicity, and enhanced oral
         absorption of AmpB.

    2. Confirming safety and efficacy in a model of Candida fungal infection.
         In a press release dated June 26, 2008, iCo provided results from a
         Candida albicans rat model. Significant antifungal activity was seen
         at dosage levels where no kidney toxicity was observed. Aspergillus
         and Candida rat models are widely accepted as predictive of what
         might be observed in a clinical setting.

    3. Generating plasma pharmacokinetic (PK) and tissue concentration data.
         Pharmacokinetic tests employing iCo-009 are currently underway,
         including studies profiling the tissue distribution, (kidney, liver,
         spleen, lung, brain and heart), in appropriate pre-clinical models.

    4. Communicating with the FDA
         On May 2, 2008, iCo held a Pre-IND meeting with the FDA to provide
         further guidance as to the regulatory path moving forward, including
         the filing of an IND. iCo continues to consult with the FDA
         concerning the proposed design of the toxicology studies in the very
         near future.

    5. Concluding CMC/Manufacturing, Safety Toxicology and a Phase I trial
         iCo is currently in the process of assessing manufacturers and
         safety toxicology studies to complete a single dose escalation
         safety and tolerability clinical trial.
    

    Assuming an expedited approach is pursued, bioequivalency rather than
superiority to existing Amphotericin B formulations will represent iCo's
clinical focus in order to seek regulatory approvals. iCo-009 was developed by
Drs. Kishor & Ellen Wasan at the University of British Columbia (UBC). iCo
Therapeutics acquired the worldwide exclusive rights to iCo-009 from UBC in
May 2008.

    About iCo Therapeutics

    iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on
redosing or reformulating drugs with clinical history for new or expanded
indications. iCo has exclusive worldwide rights to three products, iCo-007, in
Phase I for the treatment of Diabetic Macular Edema, iCo-008, a product with
Phase II clinical history to be developed for severe ocular allergies, and
iCo-009, an oral reformulation of Amphotericin B for sight and life-
threatening diseases. iCo-009 also represents a new drug delivery technology
with the potential to reprofile other parenterally administered drugs to the
oral route of administration. iCo Therapeutics trades on the TSX-Venture
exchange under the symbol "ICO". For more information, visit the company
website at: www.icotherapeutics.com

    
    No regulatory authority has approved or disapproved the content of this
    release. The TSX Venture Exchange does not accept responsibility for the
    adequacy or accuracy of this release.
    

    Forward Looking Statements

    Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on iCo
Therapeutics' current beliefs as well as assumptions made by and information
currently available to iCo Therapeutics and relate to, among other things,
anticipated financial performance, business prospects, strategies, regulatory
developments, market acceptance and future commitments. Readers are cautioned
not to place undue reliance on these forward-looking statements, which speak
only as of the date of this press release. Due to risks and uncertainties,
including the risks and uncertainties identified by iCo Therapeutics in its
public securities filings; actual events may differ materially from current
expectations. iCo Therapeutics disclaims any intention or obligation to update
or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.

    %SEDAR: 00024061E




For further information:

For further information: Business Development: Dr. John Clement, CT&DO,
(604) 602-9414 x 222; Finance Contact: Mr. John Meekison, CFO, (604) 602-9414
x 224; Investor/Media Contact: Frederica Bell, Corp. Devt., (604) 602-9414 x
228; B&D Capital, Joanne Calverly, (604) 685-6465

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